Informacje o stanowisku

Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a Regulatory Affairs Consultant - Safety/Labelling to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations.



Key responsibilities will include:

• Acting as expert for labelling-related activities
  
  
• Providing strategic labelling guidance and/or input in regulatory impact assessment, submission preparation and execution
  
  
• Developing, supporting and reviewing labelling and/or safety-related content
  
  
• Creating and maintaining the CCDS; leading and coordinating CCDS updates, coordinating and overseeing the implementation of updates into local labels
  
  
• Advising on the regulatory requirements for labelling updates in different global regions e.g. EU and ROW.
  
  
• Experienced in managing responses to regulatory authoring questions and negotiating company positions with regulatory authorities
  
  

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
  
  
• 3-5 years of experience in an industry-related environment
  
  
• Previous experience working in the pharmaceutical industry in support of Global Labelling or in a Regulatory (Clinical / Safety) role
  
  
• Experience interacting with a regulatory authorities
  
  
• Critical thinking and problem-solving skills
  
  
• Project leadership and management knowledge
  
  
• Excellent interpersonal and intercultural communication skills, both written and verbal
  
  

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